[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis (NCT07232459) | Clinical Trial Compass
RecruitingNot Applicable
[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis
China25 participantsStarted 2025-07-21
Plain-language summary
\[18F\]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene (\[18F\]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish \[18F\]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of \[18F\]FT8 PET imaging in human subjects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients (age ≥ 18 years);
. Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis.
. Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation.
Exclusion criteria
. Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.
. Pregnancy or breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The safety assessment
Timeframe: From time of injection up to 7 days post-injection
2
[18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV)
Timeframe: At the time of the single [18F]FT8 PET/CT scan (Day 1)
. Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up.
. Adult subjects (age ≥ 18 years);
. No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).
. Able to understand the study procedures and provide written informed consent. 3.2 Exclusion Criteria:
. History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder.